NCT04151407

The Study of Drug 601 in Patients With Diabetic Macular Edema (DME)

A Phase I , Multicenter, Open-Label, Single/Multiple Dose- Escalation Study of Recombinant Humanized Anti-VEGF Monoclonal Antibody Injection in Patients With Diabetic Macular Edema(DME)

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Observe the safety and tolerability of the single and multiple doses of 601 in DME patients; study the pharmacokinetic characteristics of single and multiple doses of 601, Observe the Preliminary efficacy of 601 multiple injections with different doses in the treatment of patients with DME.

Detailed description

According to the results of preclinical pharmacological research and clinical application of bevacizumab in ophthalmology Case, 601 will be developed as a drug candidate for the treatment of ocular diseases such as DME .Observe the safety and tolerability of the single and multiple doses of 601 in DME patients; study the pharmacokinetic characteristics of single and multiple doses of 601, Observe the Preliminary efficacy of 601 multiple injections with different doses in the treatment of patients with DME.

Conditions

• Diabetic Macular Edema

Interventions

Type	Name	Description
DRUG	Drug 601	Drug is a kind of recombinant anti-VEGF humanized monoclonal antibody injection.

Timeline

• Start date: 2019-03-08
• Primary completion: 2020-12-01
• Completion: 2020-12-01
• First posted: 2019-11-05
• Last updated: 2019-11-05

Locations

4 sites across 1 country: China